Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Barrier Repair

NCT07645339 | Active Not Recruiting

• 1 other identifier: ACR_EV_25-11289
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, double-blinded, placebo-controlled, prospective clinical study designed to evaluate the skin barrier repair efficacy and local tolerance of topical cosmetic formulations containing a botanical extract. Skin barrier challenge is induced via standardized tape stripping on the volar forearm of healthy subjects. The study will evaluate and compare the repair kinetics of two concentrations of the active formulation, a vehicle, and an untreated control zone over a 14-day application period.

Conditions

Impaired Barrier

Outcome Measures

Primary Outcomes (3)

• Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)

  Dermatological grading of erythema, dryness, roughness, edema, desquamation and post-inflammatory hyperpigmentation using standard clinical scales

  Baseline, Tafter, T3h, Day 1, Day 3, Day 7, and Day 14

• Hydration

  Hydration index measured using Corneometer

  Baseline, Tafter, Timm, T1h, T3h, Day 1, Day 3, Day 7, and Day 14

• TEWL

  Trans-epidermal water loss using Vapometer

  Baseline, post-stripping (Tafter), immediately post-first application (Timm), 1 hour post-first application (T1h), 3 hours post-first application (T3h), Day 1, Day 3, Day 7, and Day 14.

Secondary Outcomes (2)

• Skin Structural Changes

  Baseline, Day 3, Day 7, and Day 14

• Epidermal Proteomic and Lipidomic Profile

  Baseline, Day 7

Study Arms (4)

Active Formulation A

EXPERIMENTAL

Zones applying 0.24% active formulation

Other: Cosmetic Topical Product A

Active Formulation B

EXPERIMENTAL

Zones applying 0.05% active formulation

Other: Cosmetic Topical Product B

Vehicle Control

PLACEBO COMPARATOR

Zones applying the formulation base without active extract

Other: Vehicle

Untreated Zone

NO INTERVENTION

Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics

Interventions

Vehicle OTHER

Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days.

Vehicle Control

Cosmetic Topical Product A OTHER

Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days.

Active Formulation A

Cosmetic Topical Product B OTHER

Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days.

Active Formulation B

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese women aged 35 to 60 years in good general health.
• Self-reported dry skin type.
• a hydration index \< 35 and a trans-epidermal water loss (TEWL) ≥ 6g.m-2.h-1 on both anterior sides of the forearms at screening.
• Willingness to avoid excessive sun exposure and comply with all study procedures including tape stripping and biosampling.
• Bilateral forearms clear of scars, wounds, or significant pigment spots.

You may not qualify if:

• Current pregnancy, breastfeeding, or planning to become pregnant.
• Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products).
• History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.).
• Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis).
• Allergies to cosmetics, personal care products, or their ingredients.
• Excessive UV exposure or frequent sauna/water sports usage.
• Use of antihistamines, antibiotics, corticosteroids, or NSAIDs within the relevant washout periods.
• Participation in any other clinical trial within the past 30 days.

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

L'OREAL

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: October 13, 2025
• Primary Completion: November 3, 2025
• Study Completion (Estimated): July 25, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)